Efficacy and Safety of a Diabetes Specific Formula in Patients with Type 2 Diabetes Mellitus: A Randomized, Open-label, Crossover Study.

Authors

  • Pariya Phanachet Division of Nutrition & Biochemical Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • Andrea Hawkinson Nestlé Health Science, Metabolic Health, United States
  • Nantanat Tontrakulrat Division of Nutrition & Biochemical Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • Orawan Pichitchaipitak 4Home Health Care Nursing Unit, Division of Ambulatory Care Nursing Service, Department of Nursing, Faculty of Medicine Ramathibodi, Hospital, Mahidol University, Bangkok, Thailand
  • Nantaporn Sittikho Division of Nutrition & Biochemical Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • Jariya Boonpattararaksa Nutrition and Dietetics Unit, Ramathibodi Chakri Naruebodindra Hospital, Mahidol University, Bangkok, Thailand
  • Wanabhorn Tongchom Graduate Program in Nutrition, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • Naphat Taonam Division of Nutrition & Biochemical Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • Tanarat Lepananon Division of Nutrition & Biochemical Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • Prapimporn Chattranukulchai Shantavasinkul Division of Nutrition & Biochemical Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • Daruneewan Warodomwichit Division of Nutrition & Biochemical Medicine, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok

Keywords:

Diabetes, Diabetes specific formula, Postprandial glucose, Insulin, Glycemic index

Abstract

Managing postprandial hyperglycemia is a frequent challenge for individuals with Type 2 diabetes (T2D). There is a paucity of data examining use of a diabetes-specific formula (DSF) versus a matched isocaloric diet and improved PPG. The present study aimed to evaluate the effects of a new DSF compared to a matched macronutrient isocaloric diet on postprandial glucose (PPG), insulin, and safety in patients with T2D. In this randomized, open-label, crossover study, 30 T2D subjects were randomized into one of two groups: group A received the new DSF and group B received the isocaloric diet. After one-week, participants crossed over to the alternative nutrition intervention. Blood samples measured glucose and insulin levels at baseline, 30, 60, and 120 min post-meal. PPG levels and incremental area under the curve (iAUC) for glucose were significantly lower for group A compared to group B (P=0.007). Postprandial insulin levels were lower at 60 and 120 min for group A compared to group B, though not statistically different. The DSF was well tolerated and no serious adverse events were reported. This study demonstrates that use of a DSF is superior to an isocaloric diet in reducing PPG and tend to improving insulin response in T2D patients. These data suggest use of a DSF offers glycemic benefits and should be included as a medical nutrition therapy for patients with Type 2 diabetes.

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Published

2021-04-06 — Updated on 2022-08-08

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How to Cite

Phanachet, P., Hawkinson, A., Tontrakulrat, N., Pichitchaipitak, O., Sittikho, N., Boonpattararaksa, J., Tongchom, W., Taonam, N., Lepananon, T., Shantavasinkul, P. C., & Warodomwichit, D. (2022). Efficacy and Safety of a Diabetes Specific Formula in Patients with Type 2 Diabetes Mellitus: A Randomized, Open-label, Crossover Study. Journal of Nutrition Association of Thailand, 56(1), 1–12. Retrieved from https://he01.tci-thaijo.org/index.php/JNAT/article/view/244903 (Original work published April 6, 2021)

Issue

Vol. 56 No. 1 (2021): January-June

Section

Research article

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Upon acceptance of an article, copyright is belonging to the Nutrition Association of Thailand.